RECRUITING

Stereotactic Biopsy Split-Course Radiation Therapy in Diffuse Midline Glioma, SPORT-DMG Study

Conditions

Diffuse Midline Glioma, H3 K27M-Mutant DIPG H3K27M DMG Diffuse Midline Glioma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas. This study aims to change the way radiation is delivered, from giving 6 weeks of radiation all at once to giving 2 weeks of radiation. This may determine if there is a difference in the outcome of the treatment, and most importantly, the patients' quality of life.

Official Title

Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)

Quick Facts

Study Start:2021-10-11

Study Completion:2027-10-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05077735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age \>= 1 year(s) old (no maximum age) * Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of \>= 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign) * If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy * If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study * If biopsy has already been completed at an outside institution, the outside pathology report will be reviewed ahead of trial enrollment. The pathology specimen will then be sent to Mayo Clinic for further review, but will not delay study enrollment * Able to undergo MRI Brain * Negative urine pregnancy test completed =\< 7 days prior to registration, for women of childbearing potential only * Primary language of English or Spanish for patients and their caregiver * Patient or caregiver willing and able to provide written informed consent * Caregiver able to complete questionnaires by themselves or with assistance * Willing to return to enrolling institution for follow-up during the active monitoring phase of the study	* Any patient who has received previous radiation to the brain * Any patient who has received previous chemotherapy * Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2) * Any of the following: * Pregnant women * Nursing women * Women of childbearing potential who are unwilling to employ adequate contraception * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Other active malignancy =\< 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer * Patients \> 16 years with an Eastern Cooperative Oncology Group (ECOG) score \>= 4 and patients =\< 16 years with a Lansky play scale =\< 20

Inclusion Criteria

Exclusion Criteria

* Age \>= 1 year(s) old (no maximum age)
* Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of \>= 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign)
* If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy
* If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study
* If biopsy has already been completed at an outside institution, the outside pathology report will be reviewed ahead of trial enrollment. The pathology specimen will then be sent to Mayo Clinic for further review, but will not delay study enrollment
* Able to undergo MRI Brain
* Negative urine pregnancy test completed =\< 7 days prior to registration, for women of childbearing potential only
* Primary language of English or Spanish for patients and their caregiver
* Patient or caregiver willing and able to provide written informed consent
* Caregiver able to complete questionnaires by themselves or with assistance
* Willing to return to enrolling institution for follow-up during the active monitoring phase of the study

* Any patient who has received previous radiation to the brain
* Any patient who has received previous chemotherapy
* Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2)
* Any of the following:
* Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Other active malignancy =\< 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix
* NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
* Patients \> 16 years with an Eastern Cooperative Oncology Group (ECOG) score \>= 4 and patients =\< 16 years with a Lansky play scale =\< 20

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Principal Investigator

Anita Mahajan, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Anita Mahajan, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-11

Study Completion Date2027-10-15

Study Record Updates

Study Start Date2021-10-11

Study Completion Date2027-10-15

Terms related to this study

Keywords Provided by Researchers

DIPG
H3K27M
DMG
Diffuse Midline Glioma

Additional Relevant MeSH Terms

Diffuse Midline Glioma, H3 K27M-Mutant